Quality Assurance Manager GCP and REMS at Aegerion
Posted in General Business 30+ days ago.
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Location: Cambridge, Massachusetts
Aegerion Pharmaceuticals, Inc. is a global biopharmaceutical company with a diversified portfolio consisting of two commercially branded products and a Phase 3-ready Ultra-Orphan Fast Track and Orphan Drug designated asset.
Everyone at Novelion plays a vital role in the development and commercialization of innovative therapies for patients with debilitating rare diseases. If you are passionate about patient outcomes and enthusiastic about building a world-class, global company, we invite you to consider joining us today.
At Aegerion Pharmaceuticals we will empower you to apply your skills and ideas to achieve success. You will interact with all levels of management and take charge of your future by joining us as a Quality Assurance Manager in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Assurance Manager working on the Global Quality Team team, you will be empowered to ensure that clinical trials and REMS programs are executed with best Quality practices in compliance with GCPs and the FDA product specific REMS requirements. In this role you will focus on:
- Ensuring that clinical trials are conducted in accordance with GCP
- Conducting audits and providing Quality oversight for key vendors such as CROs, Investigator Sites, and Specialty Pharmacies, REMS Coordinating Centers and Pharmacovigilance providers
- Ensuring data integrity and QC review of Regulatory Submissions, Safety and REMS reports are included in these responsibilities
PRIMARY RESPONSIBILITES INCLUDE:
- Design, implementation and maintenance of QA systems to support GCP activities
- Ensure Risk Evaluation and Mitigation Strategy (REMS) requirements are met for two orphan drug commercial products. Work with REMS Coordinating Center and Specialty Pharmacies to develop adequate procedures and monitoring programs.
- Coordinate with cross-functional teams to ensure REMS objectives are being achieved while meeting patients and prescriber's needs
- Create risk-based audit plans for CROs, Investigator Sites, Registry Studies, Central Labs, eTMF, REMS and PV vendors
- Develop and present GCP training programs to internal and external staff
TO BE SUCCESSFUL IN THIS ROLE YOU WILL NEED:
- Minimum of bachelor's degree in the Life Sciences or HealthCare field (e.g. Nursing, Pharmacy) with 8+ years of experience in Quality Assurance
- Demonstrated knowledge of ICH E6 (R2) and 21CFR Part 11 as it applies to GCP
- Experience GCPs are untilized during clinical trials
- Hands-on experience in the interpretation and application of US, ICH, EU and other Global standards as it applies to GCPs, Registry Studies, REMS requirements, Safety and Risk Mitigation Plans
- Experience tracking CAPAs and Audits in electronic systems (e.g. Trackwise or equivalent)
- Certified auditor (or equivalent experience)
WHAT AEGERION CAN OFFER YOU:
- Small company environment where you can make a difference
- Be part of a growing commercial pharmaceutical company with a global footprint
- Full array of benefits including 401(k) match, (50% of first 6%) and an Employee Stock Purchase plan
- Three weeks' vacation along with 12 holidays
- Free parking or T-Pass reimbursement
- Tuition Reimbursement
Aegerion Pharmaceuticals is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws.
No Phone Calls or Recruiters Please.